510(k) Premarket Notification – US Food & Drug Administration

Integrated Assessment Services helps organizations to achieve 510K premarket notification in US FDA. A premarket notification, also known as a “premarket submission” or “510(k)”, is used by medical device manufacturers to show the FDA that their device is substantially equivalent (as a “predicate” or “reference”) device to another legally marketed device already on the market. This makes it easier and faster for your company to get its medical devices cleared by providing substantially less evidence from clinical trials. The 510(k) premarket notification process was established to help to speed the introduction of new devices that are “substantially equivalent” to devices already legally marketed for the same use.

The Basics: What is a 510(k)?

The 510(k) premarket notification is used by medical device manufacturers to legally market a new medical device. This process requires the submission of technical information on a predetermined form called a Premarket Notification [510(k)] Application to the Food and Drug Administration (FDA), which is evaluated by FDA scientists for safety, effectiveness, and labeling.

Some examples of devices that may be cleared through a 510(k) include, but are not limited to:

  • Devices for use in general wellness
  • Diagnostic imaging equipment (MRI, XRAY, etc.)
  • Collecting and processing blood samples
  • Surgical devices (laparoscopy, staplers, etc.)
  • Devices for diagnosing and treating illness, injury, or disease

Some devices are required by the FDA to be brought into compliance with more stringent regulations before they may be marketed. In these instances, a medical device manufacturer must receive an Investigational Device Exemption (IDE) prior to clinical trials in humans or submit a Primark Device Exemption (PMA) for a device that has already been used on humans.

Many medical device manufacturers have questions about the process of bringing a Class II or a high-risk Class III device to market in the United States, including those using an international sales subsidiary in the United States or importing devices. For instance, how can a company bring its foreign-made device to U.S. patients? How do companies obtain FDA approval for their device and market it legally in the United States?

Design History File (DHF)

The first step in this process is getting all of your ducks in a row as far as premarket evidence. This requires that your company perform a design history file (DHF). Integrated Assessment Services helps to prepare a DHF, which is a detailed record of everything your company knows about the development and marketing of the device, including copies of all pertinent documents from clinical trials, research studies, original designs, and drawings if any changes have been made to them since the device was originally introduced into interstate commerce.

A DHF is an essential step because it ensures that your company has met the legal requirements for a 510(k). The DHF should be reviewed by counsel or another professional familiar with FDA regulations to make sure it addresses all relevant issues and questions about the device’s safety, effectiveness, labeling, manufacturing processes, and controls. We are here to guide you in this process.

Integrated Assessment Services specializes in helping medical device companies and makers of high-risk Class III medical devices achieve 510k clearance for their products. Contact us today if you have any questions or would like assistance with the 510(k) premarket notification process!

FDA’s Role in the 510(k) Process

The FDA’s Center for Devices and Radiological Health (CDRH) is responsible for evaluating 510(k)s to determine if a new device is substantially equivalent to another legally marketed device, or if it is new and represents a significant advancement in the state of the art for that type of device.

The FDA will not, however, analyze or make scientific conclusions about data developed by another firm as part of an IDE or PMA application. These applications are granted only after results from clinical trials have been reviewed and found to be scientifically sound.

A 510(k) must include evidence to show that the device is as safe and effective in its proposed use as a legally marketed comparable device, or that it does not expose patients or users to any additional risk of illness or injury that would not otherwise be associated with the use of a comparable device already on the market. This means that you will have a much greater chance of 510(k) clearance if your device has been previously cleared.

If a company does not submit the required scientific information to demonstrate that its product is substantially equivalent, or cites insufficient or unclear data from an IDE or PMA application, FDA will refuse clearance and request additional information on specific aspects of the device’s safety and effectiveness.

FDA’s 510(k) Clearance Process

The 510(k) clearance process is a three-step process.

The First Step is a determination of whether the device under review is substantially equivalent to another legally marketed device. If there are no legally marketed Class I or II devices that meet this standard, FDA will determine if the device presents a high risk or if it is substantially equivalent to an investigational device.

The Second Step If FDA finds that the new device does not meet the criteria for either of these categories or if they’re unable to determine whether it does, FDA will conduct an assessment of the proposed 510(k) device’s safety and effectiveness by evaluating data from clinical trials and other scientific evidence.

The third step is a review of labeling, which includes an evaluation of the proposed device’s indications for use, contraindications, warnings, precautions, adverse reactions, potential risks and benefits (including any offsetting measures), dosage, and administration. Relevant methods to ensure that these labeling requirements are met will also be assessed during this step.

An FDA determination of substantial equivalence is only valid for specific use(s) and the device’s labeling must include all identified risks associated with that use(s).

A 510(k) also requires an annual report on any changes made to the product since its initial marketing approval or clearance. You will be required to report these changes 30 days prior to any manufacturing changes that are expected to affect the safety or effectiveness of the device.


Fees for 510k Clearance Process

The agency’s Center for Devices and Radiological Health (CDRH) has established a fee schedule to recover the costs of reviewing, referencing, and cataloging information on marketed devices. FDA will charge a fee for the review of the information you submit with your application. These fees must be paid before your application is reviewed.

The 510(k) premarket notification process can be quite involved, so it’s a good idea to understand the process in advance and begin when you’re ready – not when you need to get your device on the market.

The FDA maintains a number of databases that contain information on marketed devices, including cleared 510(k) medical device submissions to the agency. The database is updated every week and all changes must be reported immediately.

Different Types of Submissions

FDA divides 510(k) submissions into two categories:

  • Class I
  • Class II.

Class I devices are low risk and do not require a review before they’re marketed. Class II devices, however, have moderate to higher risks than Class I devices, and companies must provide scientific data to show that their device is substantially equivalent to another legally marketed device before the agency will approve it.

A 510(k) is an important document for a medical device company. It verifies to the agency that your product is in compliance with public health and safety regulations, which means you can include it on your marketing labels as an FDA-cleared device.

The 510(k) is a premarket notification to the FDA that your device is substantially equivalent to a predicate device, so you must provide detailed information on both devices.

What data is required for Submission:

The information included in a 510(k) submission should be detailed and provide evidence of the device’s performance and any potential risks associated with its use. The submission should include:

  • The intended use of the device and its description and performance characteristics;
  • Functions performed by various components of the system;
  • How the product’s design ensures safe and effective use;
  • Any performance or product characteristics that the user cannot easily evaluate.
  • A description of how the device is labeled, including what its instructions for use will be and any potential risks associated with improper usage;
  • A detailed summary of all test results from the bench and/or animal studies completed on your device;
  • A description of the device’s components and materials, including the specifications for each component or assembly, where applicable; and
  • Any additional information demonstrating that your product complies with relevant FDA regulations.

When a 510(k) is submitted to the agency:

  • There are two types of 510(k)s – Class II and Class III.
  • Class II:
  • A 510(k) notification is submitted when you want to market a product that has some, but not all, of the characteristics found in a legally marketed device that’s already been cleared by the FDA or is exempt from the review – for example, a new variation on an old model or one with different material. Class II devices are lower risk than Class III devices, but they still have the potential to cause harm.
  • Class III:
  • A 510(k) is submitted when you intend to market a product that has a similar intended use and technological characteristics as legally marketed predicate device(s), but there are important changes made in the design, material, chemical composition, energy source or manufacturing process that could significantly affect the safety or effectiveness of the device.

Validity Period:

  • There is no specified validity period for a 510(k). If you have an existing 510(k) on file with FDA and want to add new devices to that submission, you can use your original document as long as you still have all the required information on file.
  • However, if you are submitting a 510(k) for a new product that doesn’t have any similar devices already in the database, your submission must include everything listed above under “What data is required for Submission,” so it’s important to include anything that can help prove substantial equivalence at the time of submission.
  • When you submit a 510(k) to FDA, the agency’s Center for Devices and Radiological Health (CDRH), will review it within 90 days of submission to determine whether or not it’s complete. If your document is incomplete, CDRH will contact you to request additional information. The agency may also issue a “Not substantially equivalent” (NSE) letter if any deficiencies or inaccuracies are found in your 510(k).

A 510(k) is not required for all medical devices:

  • You don’t need to file a 510(k) for low-risk Class I medical devices, because they’re exempt from review by the FDA. However, to sell Class I devices in interstate commerce, they must be registered with the FDA.

A 510(k) is not required for all modifications:

  • If you only make minor changes to a Class III device that has already been cleared by the FDA, CDRH does not require a new 510(k). For example, if your company makes replacement parts for an FDA-cleared implantable device, you don’t need to submit a new 510(k) if the design of your part is not different enough from that of the original product – i.e., if it doesn’t have any additional safety or effectiveness features and performs the same function as its predecessor.
  • However, if you are making any changes to the product’s design, materials or chemical composition that could affect its safety or effectiveness – even if you’re just changing a part number – then it will be considered a new 510(k) submission.
  • If your modification alters the intended use of a device from what was already cleared by the agency, you’ll have to submit a new 510(k) and potentially conduct clinical trials.

When you already have an approved 510(k): 

  • If your device has already been through the FDA approval process, i.e., it’s been found to be substantially equivalent to a predicate device or is exempt from review, a new 510(k) isn’t required for every modification – only if safety or effectiveness is altered in any way. For example, if you modify an elbow-bearing orthosis to remove metal parts that could be metabolized and release metallic ions into the body, no further review is necessary because such a function could increase the device’s toxicity. However, if you made a similar change to a hip- or knee-bearing orthosis, you’d need to submit a new 510(k) because of the significant changes that would affect the device’s safety and effectiveness.

If you’re planning to sell your device in Europe, Japan or Canada:

  • Even if you only make minor changes to an FDA-cleared Class III device, CDRH recommends filing a new 510(k) if the modification will affect its safety or effectiveness. This is because some countries, including those in the European Union (EU), Japan, and Canada, have their own review processes that require similar information as US 510(k) submissions – even for modifications.
  • Also, certain medical devices that are not cleared by the FDA may be subject to additional regulations in other countries. For example, if you are making a Class I orthotic that’s substantially equivalent to an existing device but has some additional safety or effectiveness features (such as a pneumatic ankle-foot orthosis with Velcro closures), you would need to send it for review and approval in each country where you plan to sell it.
  • Because the US and EU share a regulatory system for medical devices, FDA and other European countries have “mutual recognition agreements” that recognize each others’ 510(k) submissions as sufficient. However, companies are required to apply for CE Marking (a type of product marking required by the EU) on any device that’s not substantially equivalent to a product already on the market in Europe. You don’t need CE Marking on your device if it is “substantially equivalent” because you can prove this by submitting a 510(k).

If you have questions about how to file a 510(k) for design modifications call IAS- Integrated Assessment Services – Email: enquiry@iascertification.com

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